I.T.S. GmbH recalls Pelvic Reconstruction System (PRS) with specific fixation screws due to higher MRI temperature risks than previously stated in instructions.
Updated MRI safety testing demonstrates higher RF-induced temperature increases under certain MRI conditions than previously reflected in the Instructions for Use (IFU).
I.T.S. GmbH is recalling pelvic reconstruction systems with certain fixation screws because MRI safety testing shows these parts could overheat during MRI scans. This could cause burns or other injuries if used improperly in MRI environments.
MRI scans use strong magnetic fields that can heat medical implants. These specific pelvic reconstruction screws were found to cause higher temperature increases than previously stated, potentially leading to burns or tissue damage during MRI procedures.
Patients using pelvic reconstruction systems with the specific fixation screws (article numbers 70312 and 70314) are affected. Medical professionals performing MRI scans on these patients are at highest risk.
Check for the fixation screw article numbers 703: 70312 (lot 26/F65133) or 70314 (lot 86/619736) on the pelvic reconstruction system.
Identify the article number on the pelvic reconstruction system to confirm if it matches the recalled screws (70312 or 70314).
Updated MRI safety testing shows these screws could overheat during MRI scans, causing burns or tissue damage.
Check the article number on the pelvic reconstruction system to see if it matches the recalled screws (70312 or 70314).
The recall record does not mention a remedy or fix for this issue.
We’ve drafted a message you can send I.T.S. GmbH to request your refund or repair — edit it as you like.
Subject: Recall Z-1600-2026 — I.T.S. GmbH I.T.S. GmbH Hello, I own a I.T.S. GmbH that is covered by recall Z-1600-2026 from I.T.S. GmbH. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
